Use of Electronic Personal Health Records to Improve Medication Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03018197
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Michael Mirro, Parkview Health

Brief Summary:
The purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Medication Adherence Other: Medication Education Not Applicable

Detailed Description:

Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.

Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
Other: Medication Education
Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.

No Intervention: No Medication Education
Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.

Primary Outcome Measures :
  1. Medication Adherence evaluated through medication possession ratios [ Time Frame: 3 months during study ]

Secondary Outcome Measures :
  1. Patient Engagement evaluated through Patient Activation Measure (PAM) [ Time Frame: 3 months during study ]
  2. Medication Knowledge evaluated through 5-question survey [ Time Frame: 3 months during study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient of Parkview Physicians Group-Cardiology
  • Currently on dabigatran for non-valvular atrial fibrillation
  • Out-patient status
  • Ability to read and understand English
  • Access to the Internet
  • Ability to utilize the computer and Internet
  • Willingness to enroll in a MyChart account

Exclusion Criteria:

  • Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks
  • Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record
  • Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
  • Currently part of another study involving another type of personal health record (other than MyChart)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03018197

United States, Indiana
Parkview Research Center; Parkview Health
Fort Wayne, Indiana, United States, 46845
Sponsors and Collaborators
Parkview Health
Centers for Medicare and Medicaid Services
Principal Investigator: Michael Mirro, MD Parkview Health
Principal Investigator: Ozlem Ersin, PhD Manchester University College of Medicine

Responsible Party: Michael Mirro, Chief Academic and Research Officer, Parkview Health Identifier: NCT03018197     History of Changes
Other Study ID Numbers: PRC13-0806 ePHR AFib pilot
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Keywords provided by Michael Mirro, Parkview Health:
Personal Health Record
Medication Knowledge
Patient Engagement

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes